SUPRIMA II MODEL 253-23

Implantable Pacemaker Pulse-generator

INTERMEDICS, INC.

The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for Suprima Ii Model 253-23.

Pre-market Notification Details

Device IDK852430
510k NumberK852430
Device Name:SUPRIMA II MODEL 253-23
ClassificationImplantable Pacemaker Pulse-generator
Applicant INTERMEDICS, INC. P.O. BOX 617 Freeport,  TX  77541 -0617
ContactLisa S Jones
CorrespondentLisa S Jones
INTERMEDICS, INC. P.O. BOX 617 Freeport,  TX  77541 -0617
Product CodeDXY  
CFR Regulation Number870.3610 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-06-10
Decision Date1985-07-17

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